Quality Products

All products are manufactured under strict quality control through cGMP (Good Manufacturing Practices) as overseen by the FDA. Our facility has also been approved to the Quality Management System Standards of ISO 13485:2003 and is applicable to the manufacture of In-Vitro diagnostic tests and reagents for professional, point of care, and self-test use for pregnancy, ovulation, urinalysis, drugs of abuse, serology, and strep products.

These certifications attest to the quality standards set and achieved for the manufacture of the entire product line.